Option granted to European Commission to
purchase up to an additional 80 million doses
Agreement reflects Moderna’s commitment to make
its vaccine available in multiple countries
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines to create a new
generation of transformative medicines for patients, today
announced that the European Commission has approved an agreement to
secure 80 million doses of mRNA-1273, Moderna’s vaccine candidate
against COVID-19, as part of the European Commission’s goal to
secure access to a safe and effective COVID-19 vaccine for
Europe.
Under the terms of the proposed agreement, the European
Commission has the option to increase their purchase of mRNA-1273,
from 80 million doses to a total of up to 160 million doses. The
agreement will be finalized following a brief review period by the
European Union Member States. This announcement follows the
conclusion of advanced exploratory talks with the European
Commission that began on August 24, 2020. Delivery of the vaccine
could begin as early as the first quarter 2021 if it is approved
for use by the European Medicines Agency (EMA) human medicines
committee (CHMP), which started a rolling review of mRNA-1273 on
November 17.
“We appreciate the confidence the European Commission has
demonstrated in our mRNA vaccine platform by including mRNA-1273 in
their portfolio of vaccines. We recognize that tackling this global
pandemic will require a number of solutions, and we are proud of
the role Moderna has been able to play in this global effort,” said
Stéphane Bancel, Chief Executive Officer of Moderna. “We have
scaled up our manufacturing capacity outside of the United States
with our strategic partners, Lonza and Rovi, to be able to deliver
approximately 500 million doses per year and possibly up to 1
billion doses per year beginning in 2021, if approved.”
In Europe, Moderna is working with its strategic manufacturing
partners, Lonza of Switzerland and ROVI of Spain, for manufacturing
and fill-finish outside of the United States. This is a dedicated
supply chain to support Europe and countries other than the United
States that enter into purchase agreements with Moderna. The
Company remains on track to manufacture 500 million to 1 billion
doses globally in 2021. If the relevant regulatory approvals are
granted, Moderna expects to begin shipping mRNA-1273 to the
European Union beginning in December 2020.
On November 16, Moderna announced that the independent, U.S.
NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3
study of mRNA-1273 has informed Moderna that the trial has met the
statistical criteria pre-specified in the study protocol for
efficacy, with a vaccine efficacy of 94.5%. This study, known as
the COVE study, enrolled more than 30,000 participants in the U.S.
and is being conducted in collaboration with the National Institute
of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH), and the Biomedical Advanced Research
and Development Authority (BARDA), part of the Office of the
Assistant Secretary for Preparedness and Response at the U.S.
Department of Health and Human Services.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a
new class of transformative medicines for patients. mRNA medicines
are designed to direct the body’s cells to produce intracellular,
membrane or secreted proteins that can have a therapeutic or
preventive benefit and have the potential to address a broad
spectrum of diseases. The company’s platform builds on continuous
advances in basic and applied mRNA science, delivery technology and
manufacturing, providing Moderna the capability to pursue in
parallel a robust pipeline of new development candidates. Moderna
is developing therapeutics and vaccines for infectious diseases,
immuno-oncology, rare diseases and cardiovascular diseases,
independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has
strategic alliances for development programs with AstraZeneca PLC
and Merck & Co., Inc., as well as the Defense Advanced Research
Projects Agency (DARPA), an agency of the U.S. Department of
Defense, and the Biomedical Advanced Research and Development
Authority (BARDA), a division of the Office of the Assistant
Secretary for Preparedness and Response (ASPR) within the U.S.
Department of Health and Human Services (HHS). Moderna has been
named a top biopharmaceutical employer by Science for the past six
years. To learn more, visit www.modernatx.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including statements regarding: the terms of the
Company’s anticipated sale of mRNA-1273 to the European Commission
and European Union Member States; the anticipated finalization of
the agreement for such sale; the timing for the delivery of
mRNA-1273 to the European Commission; plans to submit a single
marketing application to the EMA for mRNA-1273; the potential for
mRNA-1273 to be marketed in EU member states and other countries;
mRNA-1273's efficacy and its ability to prevent infection or
mitigate symptoms of COVID-19; and plans for the manufacture of
mRNA-1273 and the scale of anticipated production. In some cases,
forward-looking statements can be identified by terminology such as
“will,” “may,” “should,” “could,” “expects,” “intends,” “plans,”
“aims,” “anticipates,” “believes,” “estimates,” “predicts,”
“potential,” “continue,” or the negative of these terms or other
comparable terminology, although not all forward-looking statements
contain these words. The forward-looking statements in this press
release are neither promises nor guarantees, and you should not
place undue reliance on these forward-looking statements because
they involve known and unknown risks, uncertainties, and other
factors, many of which are beyond Moderna’s control and which could
cause actual results to differ materially from those expressed or
implied by these forward-looking statements. These risks,
uncertainties, and other factors include, among others: preclinical
and clinical development is lengthy and uncertain, especially for a
new class of medicines such as mRNA, and therefore our preclinical
programs or development candidates may be delayed, terminated, or
may never advance to or in the clinic; no commercial product using
mRNA technology has been approved and may never be approved; mRNA
drug development has substantial clinical development and
regulatory risks due to the novel and unprecedented nature of this
new class of medicines; despite having ongoing interactions with
the FDA, EMA or other regulatory agencies, the FDA, EMA or such
other regulatory agencies may not agree with the Company’s
regulatory approval strategies, components of our filings, such as
clinical trial designs, conduct and methodologies, or the
sufficiency of data submitted; the fact that the rapid response
technology in use by Moderna is still being developed and
implemented; potential adverse impacts due to the global COVID-19
pandemic such as delays in clinical trials, preclinical work,
overall operations, regulatory review, manufacturing and supply
chain interruptions, adverse effects on healthcare systems and
disruption of the global economy; and those risks and uncertainties
described under the heading “Risk Factors” in Moderna’s most recent
Quarterly Report on Form 10-Q filed with the U.S. Securities and
Exchange Commission (SEC) and in subsequent filings made by Moderna
with the SEC, which are available on the SEC’s website at
www.sec.gov. Except as required by law, Moderna disclaims any
intention or responsibility for updating or revising any
forward-looking statements contained in this press release in the
event of new information, future developments or otherwise. These
forward-looking statements are based on Moderna’s current
expectations and speak only as of the date hereof.
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version on businesswire.com: https://www.businesswire.com/news/home/20201125005570/en/
Moderna
Media: Colleen Hussey Director, Corporate Communications
617-335-1374 Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar Senior Vice President & Head of
Investor Relations 617-209-5834 Lavina.Talukdar@modernatx.com
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